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Torrent Inspection Classified as Official Action Indicated

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FDA tells Torrent Pharmaceuticals that a 9/2022 inspection of the companys India (Indrad, Gujarat) facility has been classified as...

No Evidence of Contaminated Cough Syrup in U.S.: FDA

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FDA says there is no evidence that contaminated cough syrups that have killed children in Asia and Africa have entered the U.S. su...

Panel Backs Plan to Harmonize Covid Vaccine Composition

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FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes (21 to 0) to recommend that Covid-19 vaccine co...

Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions

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FDA permanently debars former Aegerion Pharmaceuticals sales representative Mark Moffett for his role in padding his sales bonuses...

Final Guide on Compounding Ibuprofen Suspensions

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Federal Register notice: FDA releases a final guidance entitled Compounding Certain Ibuprofen Oral Suspension Products Under Secti...

Cardiosave Intra-Aortic Balloon Pumps Recalled

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Datascope/Getinge recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to the risk of blood entering the device...

Improving Myelodysplastic Syndromes Trials

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Cancer researchers from FDA and academic medical centers report recommendations from a panel of experts convened to find ways to i...

FDA Lifts Hold on Inhibikase Parkinsons Trial

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FDA lifts its clinical hold on an Inhibikase trial of its IkT 148-009 in Parkinsons disease.

BsUFA Regulatory Research Roadmap

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FDA issues a BsUFA 3 regulatory science research roadmap highlighting areas where pilot demonstration projects could improve scien...

FDA/Aetion Oncology RWD Research

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The FDA Oncology Center of Excellence and Aetion open a five-year collaboration to research oncology real-world evidence sources.